As reported by Ronald C. Chen, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in the Journal of Clinical Oncology, ASCO has endorsed, with qualifications, the 2015 Cancer Care Ontario (CCO) guideline on active surveillance for management of localized prostate cancer. ASCO did not endorse a Cancer Care Ontario recommendation that daily 5-alpha reductase inhibitor treatment may have a role in patients undergoing active surveillance.1,2 The ASCO guideline endorsement panel was co-chaired by Dr. Chen and Suneil Jain, MD, PhD, of Queen’s University Belfast.
Original CCO Guideline Questions
The major questions addressed by the CCO guideline consisted of, in brief:
(1) How does active surveillance compare with immediate active treatments as a management strategy for patients with newly diagnosed localized prostate cancer?
(2) Which findings of the following tests predict increasing risk of reclassification to a higher-risk disease state—prostate-specific antigen (PSA) kinetics, digital rectal exam, imaging, prostate cancer antigen? And what are the test characteristics?
(3) How does supplementation with 5-alpha reductase inhibitor compare with no supplementation?
(4) In patients undergoing active surveillance, how do clinical outcomes differ if treatment is managed by a single doctor vs a multidisciplinary team, urologist vs another oncologist (eg, radiation oncologist), or university/teaching hospital vs community or private clinic/hospital?
(5) In patients who are candidates for or are undergoing active surveillance, how do selection of treatment and adherence differ based on active surveillance protocol, care providers, care setting, patient factors, social support, and socioeconomic or geographic variables?
ASCO Key Recommendations
ASCO key recommendations are reproduced here, with qualifying statements by ASCO shown in bold italics.
(1) For most patients with low-risk (Gleason score ≤ 6) localized prostate cancer, active surveillance is the recommended disease management strategy.
ASCO qualifying statement: It is known that there is heterogeneity within this population, and therefore factors such as younger age, high-volume Gleason 6 cancer, patient preference, and/or African American ethnicity should be taken into account in this recommendation. Young patients (younger than age 55 years) with high-volume Gleason 6 cancer should be closely scrutinized for the presence of higher-grade cancer, and definitive therapy may be warranted for select patients. For patients with a limited life expectancy (< 5 years) and low-risk cancer, watchful waiting may be more appropriate than active surveillance.
(2) Active treatment (radical prostatectomy or radiation therapy) is recommended for most patients with intermediate-risk (Gleason score 7) localized prostate cancer. For select patients with low-volume, intermediate-risk (Gleason 3 + 4 = 7) localized prostate cancer, active surveillance may be offered.
ASCO qualifying statement: Patients with Gleason score 7 (3 + 4) being considered for active surveillance should include only those men with low-volume Gleason pattern 4 pathology and/or age older than 75 years. Because of known interobserver variability associated with the identification of minor Gleason pattern 4 elements, prospective intradepartmental consultation with colleagues should be considered a cornerstone of quality assurance in this area. For patients with a limited life expectancy (< 5 years), watchful waiting may be more appropriate than active surveillance.
(3) The active surveillance protocol should include the following tests: a PSA test every 3 to 6 months; digital rectal exam at least every year; at least a 12-core confirmatory transrectal ultrasound-guided biopsy (including anterior-directed cores) within 6 to 12 months, and then serial biopsy every 2 to 5 years thereafter or more frequently if clinically warranted. Men with a limited life expectancy may transition to watchful waiting and avoid further biopsies.
Use of ancillary tests beyond digital rectal exam, PSA, and biopsy to improve patient selection or as part of monitoring in an active surveillance regimen remains investigational.
They could include multiparametric magnetic resonance imaging and/or genomic testing. Multiparametric magnetic resonance imaging and genomic testing may be indicated when a patient’s clinical findings are discordant with the pathologic findings and could be useful in identifying occult cancers or changes indicative of tumor progression in patients at risk. These tests may also be helpful when the decision regarding active surveillance vs active treatment is uncertain (eg, in cases of low-volume Gleason 3 + 4). Multiparametric magnetic resonance imaging should not be used as a replacement for rebiopsy.
For patients undergoing active surveillance who are reclassified to a higher-risk category, defined by repeat biopsy showing Gleason score ≥ 7 and/or significant increases in the volume of Gleason 6 tumor, consideration should be given to active therapy (eg, radical prostatectomy or radiation therapy).
As noted, ASCO did not endorse the following CCO recommendation: “Daily 5-alpha reductase inhibitors may have a role in men receiving active surveillance.” ■
Disclosure: For full disclosures of the study authors, visit www.jco.ascopubs.org.
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